| 日期： | 2023/01/09 |
|---|---|
| 作者： | United Kingdom |
| 文件編號： | G/MA/QR/N/GBR/2/Add.1 |
| 附件下載： | GMAQRNGBR2A1.pdf |
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NOTIFICATION PURSUANT TO THE DECISION ON NOTIFICATION PROCEDURES
FOR QUANTITATIVE RESTRICTIONS (G/L/59/Rev.1)
United Kingdom
Addendum
The following communication, dated 3 January
2023, is being circulated at the request of the delegation of the United
Kingdom.
|
A. Notifying Member: United
Kingdom |
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B. Date of notification: 3 January 2023 |
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C. First time notification: Yes No, last notification was made in (doc. symbol):
G/MA/QR/N/GBR/2 |
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D. Type of notification: 1. Complete (i.e. notification of all quantitative
restrictions in force) 2. Changes
to a notification previously made in G/L/59/REV.1 which are of the following nature: 2.1 Introduction of new restrictions, as listed
in Section 1. 2.2 Elimination of restrictions, as described
in G below. 2.3 Modification of a previously notified
restriction, as described in Section 1. 3. Reverse notification of restrictions
maintained by (Member): |
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E. The
notification provides information for the following biennial period
(e.g. 2012‑2014): 2022-2024 and relates to restrictions in
force as of 20 December 2022 |
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F. This notification contains information* relating to: Section 1: List of quantitative restrictions that are
currently in force. Section 2: Cross-reference to other WTO notifications with
information on quantitative restrictions that are currently in force and
additional information. |
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G. Comments of a
general nature, including a description of the elimination of restrictions
notified under D.2.2 and the date they ceased to be in force. 1.
This
addendum modifies and replaces QR No. 21 of G/MA/QR/N/GBR/2. This notification updates
the list of commodity codes applicable to the medicines in scope and provides
appropriate information on the product descriptions. |
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2.
The
UK is notifying the reduction of 10 medicines from the list of medicines,
placed on the UK market, which are subject to limited export restrictions.
These medicines no longer meet the tests set to maintain measures. These are:
Anakinra, Budesonide, Calcium Chloride,
Colestyramine, Dexmedetomidine, Epoprostenol, Milrinone, Rifampicin,
Rivaroxaban and Salbutamol. Insulin
human has also been removed as this is the same product as insulin
soluble human. |
|
3. The UK is also notifying the addition of 10 medicines to the list in
critical short supply, in lieu of other shortage mitigations taking effect. 4. Amoxicillin, Phenoxymethylpenicillin (Penicillin V),
Flucloxacillin (3004.10.00); Cefalexin and Azithromycin (3004.20.00)
are antibiotics used in the treatment of Streptococcal A infections. Measures
are in place while the Department of Health and Social Care (DHSC) work
across the supply chain to bring forward stock and expedite deliveries,
ensure antibiotic orders are proportionate, and issue directions to utilise
alternative medicines where appropriate. 5.
Alteplase and
Tenecteplase (3004.90.00) are
used for a number of critical indications including ischaemic stroke,
myocardial infarction and pulmonary embolism for which there is no
alternative treatment. Oseltamivir
and Zanamivir (3004.90.00) are antiviral medicines used to treat
and prevent influenza. Semaglutide
(3004.90.00) is a critical drug used to treat patients with Type 2 diabetes.
Measures are in place while DHSC
works with healthcare bodies to ensure continued access to treatment, and
while Serious Shortage Protocols (SSPs) take effect, enabling Pharmacists to
issue alternative medicines where available to manage shortages. |
|
6.
These
are temporary measures, in place to relieve critical shortages of medicines
necessary for the protection of human health. Measures are reviewed regularly
and only applied where the critical need cannot be met by alternative
measures. On 15 December 2021, 47 medicines were removed from the
list. On 24 June 2022, a further 30 (net) medicines were removed from the
list. |
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7.
The
UK's notification G/MA/QR/N/GBR/2 included details relating to Northern Ireland. This notification does
not amend those details which continue to apply |
Section 1: List of quantitative restrictions that are currently in force
|
QRNo. |
General description
of the restriction |
Type of restriction
|
Tariff line code(s)
affected, based on HS (2017) |
Detailed Product
Description |
WTO Justification
and Grounds for Restriction, e.g. Other International Commitments |
National legal
basis and entry into force |
Administration,
modification of previously notified measures, and other comments |
|
1 |
2 |
3 |
4 |
5 |
6 |
7 |
|
|
1 |
Measures to regulate exports of certain
medicaments. |
CP-X |
Medicines
fall under the following commodity codes: |
1.
Heading 3002 - Classification Human
blood; animal blood prepared for therapeutic, prophylactic or diagnostic
uses; antisera, other blood fractions and immunological products, whether or
not modified or obtained by means of biotechnological processes; vaccines,
toxins, cultures of micro-organisms (excluding yeasts) and similar products;
cell cultures, whether or not modified
Product Description
per Commodity Code under Heading 3002
|
Article
XX(b) GATT Protection
of human, animal or plant life or health.
|
Regulation
43(2) of the Human Medicines Regulations 2012 requiring wholesale dealers to
ensure continued supply of medicinal products so that the needs of patients
in the UK are met. Further details can be found through: https://www.legislation.gov.uk/uksi/2012/1916/contents/made
The
date restrictions came into effect varies by medicine; this is specified for
each medicine on the list, last updated on 20 December 2022 and
available on gov.uk at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1125639/restricted_medicines_list_19_december_2022_v.1.csv
|
The
list of medicines is maintained by the Department of Health and Social Care.
These
measures are reviewed regularly. A
full change log of previous measures, from October 2019, can be found here: https://www.gov.uk/government/publications/medicines-that-cannot-be-parallel-exported-from-the-uk
Medicines
included on this list meet the following conditions: ·
The medicine is required to meet the needs of UK patients ·
The medicine is currently in shortage or risk of being in
shortage ·
The export of the medicine would contribute to or
exacerbate a shortage, or risk of shortage, of that medicine in the UK |
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2. Heading 3004 - Classification Medicaments
consisting of mixed or unmixed products for therapeutic or prophylactic uses,
put up in measured doses (including those in the form of transdermal
administration systems) or in forms or packings for retail sale
structure,
or streptomycins or their derivatives
|
|
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Medicines on this list which have been
produced to fulfil contracts overseas are not subject to restriction. As
such, restrictions only apply to wholesaler dealer licence holders that are
not the market authorization holder for a medicine intended for export. The measures
are designed to ensure wholesalers fulfil their legal obligations to maintain
supply to UK patients.
These restrictions are only applied and
maintained where
alternative measures are not considered
sufficient on their own to ensure that UK supply meets demand.
A number of exemptions apply to medicines
in scope of these restrictions. For example, exports destined for
international humanitarian organizations such as COVAX are not covered. A
full list of exemptions can be found at: https://www.gov.uk/guidance/parallel-export-and-hoarding-of-restricted-medicines
|
|
|
|
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3004.32.00 |
Containing
corticosteroid hormones, their derivatives or structural analogues
|
|
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Requests
for exemptions are considered on a case-by-case basis. These can be submitted
by a foreign government or government agency, or a
wholesaler on their behalf at: restrictedmedicines@dhsc.gov.uk
Further information on these measures
is available here: https://www.gov.uk/guidance/parallel-export-and-hoarding-of-restricted-medicines
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Further
detail of these medicines can be found at: https://www.gov.uk/government/publications/medicines-that-cannot-be-parallel-exported-from-the-uk
|
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It is the responsibility of the wholesaler to ensure any exports are
made or withheld in compliance with these restrictions. Failure to comply
with these restrictions may lead to regulatory action by the Medicines and
Healthcare products Regulatory Authority (MHRA) against the wholesale
dealer's licence. |
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